Group 1 - The core point of the news is that Baihua Pharmaceutical's controlling shareholder and actual controllers have their agreement to act in concert expire, which will not adversely affect the company's management or change its controlling shareholder [1] - The expiration of the agreement is a routine corporate governance action, and the company confirms that it will not impact daily operations [1] - Such agreements not being renewed after expiration is common in the A-share market [1] Group 2 - YKYY018 aerosol inhalation agent from Yuyuan Pharmaceutical has received clinical trial approval from both Chinese and U.S. regulatory authorities for the prevention and treatment of respiratory syncytial virus (RSV) infections [2] - This product addresses a significant clinical need, particularly in high-risk populations, and utilizes an innovative aerosol inhalation delivery method [2] Group 3 - HeYu Pharmaceutical's oral small molecule KRAS G12D inhibitor, ABSK141, has received IND approval from the U.S. FDA for treating patients with advanced solid tumors carrying the KRAS G12D mutation [3] - This drug targets a common oncogenic mutation associated with several cancers, including pancreatic and colorectal cancer, indicating a pressing clinical demand [3] Group 4 - The China Drug Price Registration System has been officially launched, aimed at providing authoritative and accurate drug price information to support the internationalization of pharmaceutical companies [4] - This system is a key step towards establishing a scientific and transparent pricing system for innovative drugs in China, facilitating high-quality development in the pharmaceutical industry [4]

YKYY018雾化吸入剂是悦康科创依托全流程AI平台，自主开发的一款国际原创的膜融合抑制剂药物， 用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗。该产品具有全新的作用机制， YKYY018能够与呼吸道合胞病毒融合蛋白（F蛋白）F1亚基的七肽重复序列区1（HR1）特异性结合， 抑制病毒自身HR1与HR2结构域之间同源6-HB的形成，阻断病毒与宿主细胞的融合过程，实现抗病毒效 果，兼具治疗和预防的双重功能。公司已获得该产品的核心专利授权，并拥有其全球独占权益。 格隆汇12月2日丨悦康药业(688658.SH)公布，公司全资子公司北京悦康科创医药科技股份有限公司（简 称"悦康科创"）于近日获得国家药品监督管理局（简称"NMPA"）核准签发的关于同意YKYY018雾化吸 入剂用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准 通知书》，公司将开展本品I期临床试验。 ...

智通财经APP讯，悦康药业(688658.SH)发布公告，公司全资子公司北京悦康科创医药科技股份有限公 司(简称"悦康科创")于近日获得国家药品监督管理局(简称"NMPA")核准签发的关于同意YKYY018雾化 吸入剂用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批 准通知书》，公司将开展本品I期临床试验。 ...

悦康药业(688658.SH)发布公告，公司全资子公司北京悦康科创医药科技股份有限公司(简称"悦康科创") 于近日获得国家药品监督管理局(简称"NMPA")核准签发的关于同意YKYY018雾化吸入剂用于与呼吸道 合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准通知书》，公司将 开展本品I期临床试验。 ...

悦康药业公告称，其全资子公司悦康科创近日获国家药监局核准签发的关于YKYY018雾化吸入剂两份 《药物临床试验批准通知书》，同意用于与呼吸道合胞病毒患者接触后的暴露后预防和RSV感染的治 疗，公司将开展I期临床试验。该产品是国际原创的膜融合抑制剂药物，已获核心专利授权及全球独占 权益，近日也获美国FDA临床试验批准函告。不过，药品研发存在周期长、环节多、风险高的特点，公 司提醒投资者注意风险。 ...

人民财讯12月2日电，悦康药业(688658)12月2日公告，公司全资子公司北京悦康科创医药科技股份有限 公司近日获得国家药监局核准签发的关于同意YKYY018雾化吸入剂用于与呼吸道合胞病毒患者接触后 的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准通知书》，公司将开展本品I期临床试 验。 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has increased its R&D investment, and its innovative pipeline is gradually entering a harvest period. The FDA has approved the clinical trial for the YKYY018 aerosol inhalation agent for the prevention and treatment of RSV infections. Despite facing pressure on its operating performance in 2025, the company is optimistic about its long-term growth potential due to its innovative layout and small nucleic acid technology platform [3][4] Financial Performance Summary - For the first three quarters of 2025, the company achieved revenue of 1.759 billion yuan, a year-on-year decrease of 41.20%. The net profit attributable to the parent company was -148 million yuan, down 170.56% year-on-year. The non-recurring net profit attributable to the parent company was -168 million yuan, a decrease of 182.95% year-on-year [3][4] - The company has adjusted the price of its "Ginkgo Leaf Extract Injection" at the end of 2024, which has impacted its performance. The R&D expenses have increased significantly, contributing to the net profit decline [3][4] - The sales expense ratio for the first three quarters of 2025 was 28.64%, down 7.37 percentage points; the management expense ratio was 10.67%, up 5.18 percentage points; the R&D expense ratio was 18.00%, up 9.27 percentage points; and the financial expense ratio was 0.59%, up 0.47 percentage points [3][4] Earnings Forecast - The revised earnings forecast for the company indicates net profits attributable to the parent company of -183 million yuan, -53 million yuan, and 69 million yuan for 2025, 2026, and 2027 respectively. The original forecasts were 51 million yuan, 206 million yuan, and 561 million yuan [3][4] - The expected EPS for 2025, 2026, and 2027 is -0.41 yuan, -0.12 yuan, and 0.15 yuan respectively, with the current stock price corresponding to P/E ratios of -60.6, -208.5, and 161.2 times [3][4] Innovative Pipeline Progress - The company is advancing its innovative drug pipeline, with key traditional Chinese medicine (TCM) drugs in the final review stage for NDA. The small nucleic acid innovative drugs YKYY015 and YKYY029 have received approval for clinical trials in the US and China, with ongoing Phase I trials domestically [4] - The RSV mRNA vaccine YKYY025 and VZV mRNA vaccine YKYY026 have also received approval for clinical trials in the US. The company has completed the Phase IIa clinical trial for its first domestic antisense nucleic acid drug for primary liver cancer [4]

Core Viewpoint - YKYY018 aerosol inhalation agent developed by the company has received FDA approval for clinical trials aimed at preventing and treating respiratory syncytial virus (RSV) infections, highlighting a significant advancement in the company's drug development capabilities [1][4]. Group 1: FDA Approval and Clinical Trials - The FDA has granted approval for the clinical trial of YKYY018 aerosol inhalation agent, allowing the company to proceed with the study as per the submitted protocol [1]. - The IND number for the clinical trial is 178457, and the application is specifically for the prevention and treatment of RSV infections [4]. Group 2: RSV Infection Overview - RSV is a highly infectious RNA virus that primarily affects children, the elderly, and immunocompromised individuals, with approximately 90% of children infected by the age of two [2]. - Globally, RSV is the leading cause of lower respiratory tract infections in children under five, resulting in about 3.6 million hospitalizations and approximately 100,000 deaths annually [2]. - In 2024, it is estimated that 91.4 million children under five will be infected with RSV worldwide, with 13.4 million cases in China [2]. Group 3: YKYY018 Product Details - YKYY018 is an innovative membrane fusion inhibitor developed using a full-process AI platform, designed to prevent and treat RSV infections [3]. - The drug works by specifically binding to the F protein of RSV, blocking the fusion process between the virus and host cells, thus providing both therapeutic and preventive effects [3]. - The company holds core patent rights for YKYY018, granting it global exclusive rights [3]. Group 4: Preclinical Research Findings - Preclinical studies have shown that YKYY018 effectively inhibits various RSV strains and clinical isolates, demonstrating significant antiviral activity [5]. - In animal models, the drug significantly reduced viral loads and alleviated lung tissue damage, indicating its potential efficacy [5]. - Safety assessments in animal trials revealed no significant adverse effects on respiratory function or other health indicators, suggesting good safety and tolerability [5].

Core Viewpoint - Yuyuan Pharmaceutical's subsidiary has received FDA approval for clinical trials of YKYY018 aerosol inhalation solution aimed at preventing and treating respiratory syncytial virus (RSV) infections [1] Group 1: Company Developments - Yuyuan Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., has obtained FDA consent for clinical trials of YKYY018 [1] - The drug YKYY018 is a membrane fusion inhibitor that specifically binds to the HR1 region of the RSV fusion protein, blocking the fusion process between the virus and host cells [1] Group 2: Product Details - YKYY018 aerosol inhalation solution has dual functions for both treatment and prevention of RSV infections [1] - The mechanism of action involves inhibiting the formation of the homologous 6-HB structure between HR1 and HR2 domains of the virus [1]

Core Viewpoint - YKYY018 aerosol inhalation agent developed by Yuyuan Pharmaceutical has received FDA approval for clinical trials, marking a significant step in addressing the unmet medical need for RSV infection treatment globally, as no such drug has been approved for market yet [1] Company Summary - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kexin Pharmaceutical Technology Co., Ltd., has obtained FDA approval for YKYY018 to be used in clinical trials for the prevention and treatment of RSV infection [1] - YKYY018 is an internationally original membrane fusion inhibitor drug developed through a comprehensive AI platform [1] Industry Summary - There is a significant and urgent unmet medical need in the clinical treatment field for RSV infections, as there are currently no approved drugs available globally for this indication [1]